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Clinical Chemistry 45: 206-212, 1999;
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(Clinical Chemistry. 1999;45:206-212.)
© 1999 American Association for Clinical Chemistry, Inc.


Articles

Multicenter Clinical and Analytical Evaluation of the AxSYM Troponin-I Immunoassay to Assist in the Diagnosis of Myocardial Infarction

Fred S. Apple1,a, Andrew J. Maturen2, Richard E. Mullins3, Pennell C. Painter4, Melissa S. Pessin-Minsley5, Robert A. Webster2, Jennifer Spray Flores2, Robert DeCresce2, Daniel J. Fink5, Patrice M. Buckley5, Julie Marsh1, Vincent Ricchiuti1 and Robert H. Christenson6

1 Hennepin County Medical Center, Minneapolis, MN 55415.

2 Rush Presbyterian St. Luke's Medical Center, Chicago, IL 60612.

3 Emory University Hospital, Atlanta, GA 30322.

4 University of Tennessee Memorial Hospital, Knoxville, TN 37920.

5 Columbia Presbyterian Medical Center, New York, NY 10032.

6 University of Maryland School of Medicine, Baltimore, MD 21201.
a Address correspondence to this author at: Hennepin County Medical Center, Clinical Laboratories 812, 701 Park Ave., Minneapolis, MN 55415. Fax 612-904-4229; e-mail fred.apple{at}co.hennepin.mn.us.

We evaluated the AxSYM troponin I (cTnI) immunoassay for assisting in the detection of acute myocardial infarction (AMI). At four sites, the total imprecision (CV) over 20 days was 6.3–10.2%. The minimum detectable concentration was 0.14 ± 0.05 µg/L. Comparison of cTnI measurements between the AxSYM and Stratus (n = 406) over the dynamic range of the AxSYM assay demonstrated good correlation, r = 0.881, with a proportional bias: AxSYM cTnI = 3.50(Stratus cTnI) - 1.10. The confidence intervals (95%) for the slope and intercept were 3.39–3.64 and -1.32 to -0.95, respectively. The expected cTnI concentration in healthy individuals was <=0.5 µg/L, whereas the ROC curve-determined cutoff for AMI was 2.0 µg/L. This gave a diagnostic sensitivity of 91.8% and specificity of 92.4% when tested in serial samples collected within 24 h of admission in 633 patients presenting with chest pain, of which 122 had an AMI. The concordances of the AxSYM cTnI with the Stratus cTnI, OPUS cTnI, and Access cTnI were 95.3%, 95.1%, and 94.3%, respectively, from patients with suspected AMI. The AxSYM cTnI demonstrated excellent clinical specificity, >=96%, in skeletal muscle injury, chronic renal disease, and same-day noncardiac surgery patients.




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